The Phillips Firm and Hodes Milman file lawsuit against device manufacturer Medtronic, Inc.
Accusing Medtronic, Inc., of encouraging doctors to use its bone-growth products in ways not approved by the Federal Drug Administration (FDA), commonly referred to as “off label” use, Sanders Viener Grossman, LLP recently filed its first lawsuit (along with The Philips Firm and Hodes Milman Liebeck Mosier ) against Medtronic and Medtronic Sofamor Danek in Los Angeles Superior Court, California. This is not the first lawsuit filed and many more are expected to be forthcoming
In this first case, Hayter v. Medtonic, Inc., plaintiff Daryl Hayter, from San Diego, California alleges he was severely injured when the Medtronic “Infuse®” bone growth product was implanted into his lumbar spine during his back surgery.
According to the complaint, unbeknownst to Mr. Hayter, Infuse® had not been approved by the FDA for use in the type of surgery Mr. Hayter received. The FDA only approved use of Infuse® for specific back surgeries that involve an anterior approach, in which the surgeon operates on the spine from the front part of the body through the abdomen, rather than a posterior approach involving insertion through the back. Mr. Hayter’s back surgery involved a posterior approach, and therefore, is considered an “off label” use.
The complaint states “Infuse® is a bio-engineered liquid bone graft product classified by the FDA as a medical device. It was designed, manufactured and marketed by a division of Medtronic, Inc., known as Medtronic Sofamor Danek USA, Inc.” Infuse® is used in spinal fusion surgeries “to accomplish the same outcome as implanting a patient's own bone or cadaver bone between the vertebrae in the spine, obviating the necessity of harvesting bone from the patient's own hip.”
Specifically, the FDA-approved use of Infuse® in anterior-approach lumbar surgeries involve the surgeon first placing a Medtronic "LT Cage" in the spine. An LT Cage is a hollow metal cylinder placed between a patient’s vertebrae which holds a sponge filled with liquid Infuse. The Infuse® filled sponge causes bone growth in an attempt to fuse the vertebrae together. The problem is that Infuse can cause uncontrolled bone growth, which can be very dangerous to the patient.
The complaint alleges that, “[d]espite this lack of FDA approval, and the FDA's explicit concerns about the dangers to patients of off-label uses, Infuse® was improperly promoted by the MEDTRONIC Defendants to be used off-label for posterior approach lumbar spine fusions, for cervical spine fusions, and without an LT-Cage™.” Infuse® is not approved by the FDA for use in cervical spine surgery, or for any lumbar surgery performed through the back or side of the body (posterior approaches).
According the to complaint, injuries that can occur with off-label use of Infuse® include “Infuse® -induced bone overgrowth and other complications that often necessitate risky,
painful, and costly revision surgeries, which may not cure the problems caused by the Infuse® use. This uncontrolled bone growth (also known as ‘ectopic’ or ‘exuberant’ bone
growth) can result in severe damage to or compression of the surrounding neurologic structures in the spine, and bone can grow onto or around the spinal cord or the spinal nerve roots. When nerves are compressed by such excessive bone growth, a patient can experience, among other adverse events, intractable pain, paralysis, spasms, and the need for revision surgery.”
Additional injuries alleged include “extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, and worse overall outcomes.”